Long-Term Safety Of PF-00547659 In Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: 75mg SHP647 (PF-00547659)Drug: 225mg SHP647 (PF-00547659)
- Registration Number
- NCT01771809
- Lead Sponsor
- Shire
- Brief Summary
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- Subjects between 18 and 66 years of age.
- Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.
- Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study.
- Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHP647 75 mg 75mg SHP647 (PF-00547659) Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. SHP647 225 mg 225mg SHP647 (PF-00547659) Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) From start of study drug administration up to 168 weeks An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Mucosal Healing at Week 16 Week 16 Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment \[PGA\]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.
Serum Trough Concentrations of SHP647 Versus Time Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156 Serum trough concentrations of SHP647 versus time was reported.
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) Baseline, Week 8, 16, 24, 40, 48, 64 and 156 The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64. The number of participants with positive ADA was reported.
Number of Participants With Positive Neutralizing Antibodies (NAb) Baseline, Week 8, 16, 24, 40, 48, 64 and 156 The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (\>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64.
Trial Locations
- Locations (99)
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Mayo Clinic Arizona - Scottsdale
🇺🇸Scottsdale, Arizona, United States
University Hospital Gasthuisberg
🇧🇪Leuven, Belgium
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Nevada School of Medicine
🇺🇸Las Vegas, Nevada, United States
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
AKH Wien, Universitaetsklinik fuer Innere Medizin III
🇦🇹Wien, Austria
The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Centrum Endoskopii Zabiegowej
🇵🇱Bydgoszcz, Kujawsko-Pomorskie, Poland
Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.
🇵🇱Lodz, Wojlodzkie, Poland
Albany Medical College
🇺🇸Albany, New York, United States
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Percuro Clinical Research, Ltd
🇨🇦Victoria, British Columbia, Canada
Rocky Mountain Gastroenterology
🇺🇸Thornton, Colorado, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Bassan and Bloom M.D.s
🇺🇸Miramar, Florida, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Atlanta Gastroenterology Specialists, PC
🇺🇸Suwanee, Georgia, United States
Commonwealth Clinical Studies
🇺🇸Brockton, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Center for Digestive and Liver Diseases
🇺🇸Mexico, Missouri, United States
Minnesota Gastroenterology, PA
🇺🇸Plymouth, Minnesota, United States
Premier Medical Group of the Hudson Valley, PC
🇺🇸Poughkeepsie, New York, United States
The Oregon Clinic-West Hills Gastroenterology Associates, P.C.
🇺🇸Portland, Oregon, United States
UNC Memorial Hospital
🇺🇸Chapel Hill, North Carolina, United States
Weill Cornell Medical College of Cornell University
🇺🇸New York, New York, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Baylor College Of Medicine - Baylor Medical Center
🇺🇸Houston, Texas, United States
McGuire DVAMC
🇺🇸Richmond, Virginia, United States
Univeristy of Washington
🇺🇸Seattle, Washington, United States
Allegiance Research Specialists
🇺🇸Wauwatosa, Wisconsin, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Mater Health Services
🇦🇺South Brisbane, Queensland, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
AZ St. Elisabeth Herentals
🇧🇪Herentals, Belgium
MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
🇧🇬Sofia, Bulgaria
(G.I.R.I.) GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
Centre Hospitalier de Mouscron
🇧🇪Mouscron, Belgium
Hamilton Health Sciences Corp, McMaster Univ Medical Centre
🇨🇦Hamilton, Ontario, Canada
Taunton Surgical Centre
🇨🇦Oshawa, Ontario, Canada
IBD Clinical and Research Centre
🇨🇿Prague, Czechia
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
🇨🇦Montreal, Quebec, Canada
Hepato-Gastroenterologie HK s.r.o. Poliklinika III
🇨🇿Hradec Kralove, Czechia
Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem
🇨🇿Usti nad Labem, Czechia
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
🇫🇷Caen, France
CHU De Nice Hopital De L'Archet II
🇫🇷Nice Cedex 03, France
Hopital Huriez CHRU de Lille
🇫🇷Lille, France
CHU de Saint-Etienne Hopital Nord
🇫🇷Saint Priest En Jarez, France
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany
Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit
🇮🇱Jerusalem, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Universita' degli Studi "Magna Graecia" di Catanzaro
🇮🇹Catanzaro, Italy
Meir Medical Center
🇮🇱Kfar-Saba, Israel
The Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, Italy
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Waikato Hospital
🇳🇿Hamilton, New Zealand
Christchurch Hospital
🇳🇿Christchurch, Canterbury, New Zealand
University Medical Center Groningen (UMCG)
🇳🇱Groningen, Netherlands
Gabinet Endoskopii Przewodu Pokarmowego
🇵🇱Krakow, Poland
NZOZ Centrum Medyczne HCP sp. z o.o
🇵🇱Poznan, Poland
Klinika Chorob Wewnetrznych I Gastroenterologii
🇵🇱Warszawa, Poland
St. Petersburg State Medical Academy for Postgraduate Education
🇷🇺Saint-Petersburg, Russian Federation
Lexmedica
🇵🇱Wroclaw, Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
🇵🇱Warszawa, Poland
Clinical Hospital Centre Bezanijska Kosa
🇷🇸Belgrade, Serbia
Military Medical Academy
🇷🇸Belgrade, Serbia
Clinical Hospital Center Zemun
🇷🇸Belgrade, Serbia
Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica
🇸🇰Nitra, Slovakia
Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica
🇸🇰Ruzomberok, Slovakia
Kingsbury Hospital
🇿🇦Claremont, Cape Town, South Africa
Gastro L., s.r.o.
🇸🇰Presov, Slovakia
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Centro Medico Teknon-Institut de la Macula i de la Retina
🇪🇸Barcelona, Spain
Parc de Salut Mar-Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Milan University, Humanitas Clinical Institute
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
🇮🇹Roma, Italy
Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Italy
Universita Cattolica del Sacro Cuore
🇮🇹Roma, Italy
London Health Sciences Centre - University Hospital
🇨🇦London, Ontario, Canada
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Community Clinical Trials
🇺🇸Orange, California, United States
UCSD Altman Clinical and Translational Research Institute
🇺🇸La Jolla, California, United States
CHU de Nancy - Hopital Brabois
🇫🇷Vandoeuvre les Nancy, France
CHU Amiens-Picardie - Hopital Sud
🇫🇷Amiens, France
Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1
🇩🇪Regensburg, Germany
Csongrad Megyei Dr. Bugyi Istvan Korhaz
ðŸ‡ðŸ‡ºSzentes, Csongrad, Hungary
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of